Different Therapies in Treating Infants With Newly Diagnosed Acute Leukemia
Recruitment status was Recruiting
|First Received Date ICMJE||October 22, 2007|
|Last Updated Date||January 12, 2011|
|Start Date ICMJE||June 2007|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Disease-free survival [ Designated as safety issue: No ]|
|Original Primary Outcome Measures ICMJE
|Change History||Complete list of historical versions of study NCT00550992 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Different Therapies in Treating Infants With Newly Diagnosed Acute Leukemia|
|Official Title ICMJE||International Collaborative Treatment Protocol for Infants Under One Year With Acute Lymphoblastic or Biphenotypic Leukemia|
RATIONALE: Giving chemotherapy before a donor stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine, methotrexate, leucovorin, and antithymocyte globulin before and after transplant may stop this from happening. It is not yet known which treatment regimen is most effective in treating acute leukemia.
PURPOSE: This randomized clinical trial is studying how well different therapies work in treating infants with newly diagnosed acute leukemia.
OUTLINE: This is a multicenter study.
NOTE: *Patients with CNS involvement at initial diagnosis also receive MTX IT on days 8 and 22. If CNS leukemia is still present at day 29, then patients receive weekly MTX IT until the CNS is free of leukemia.
After completion of induction therapy, patients are stratified according to risk group (low-risk [LR] vs medium-risk [MR] vs high-risk [HR]). Patients with low-risk disease are assigned to treatment arm I. Patients with MR or HR disease that is in complete remission (CR) on day 33 are randomized to 1 of 2 treatment arms. These patients are stratified according to status (MR with rearranged MLL vs MR with unknown MLL vs HR).
All HR patients with a suitably matched donor are scheduled for allogeneic stem cell transplantation (SCT) after MARMA or before or during OCTADA(D) chemotherapy, provided they are in CR1 and no more than 8 months have elapsed since initial diagnosis.
After completion of study therapy, patients are followed periodically for up to 2 years.
|Study Type ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Allocation: Randomized
Primary Purpose: Treatment
|Study Arm (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||445|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
PRIOR CONCURRENT THERAPY:
|Ages||up to 1 Year|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Not Provided|
|Location Countries ICMJE||United States, Austria, Belgium, Czech Republic, France, Germany, Italy, Netherlands, United Kingdom|
|NCT Number ICMJE||NCT00550992|
|Other Study ID Numbers ICMJE||CDR0000570260, DCOG-INTERFANT-06, EUDRACT-2005-004599-19, CCLG-LK-2006-10|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Dutch Childhood Oncology Group|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Cancer Institute (NCI)|
|Verification Date||June 2009|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP